Ziccum has proven excellent mRNA activity in animal study with LaminarPace material

Ziccum AB (publ) has performed an animal study, confirming excellent genetic activity of mRNA/LNP materials treated by LaminarPace. The in-vivo data confirms the ability of Ziccum’s LaminarPace technology to transform delicate mRNA/LNP liquid solution into stable dry powder form, now proving the preserved mRNA activity also in animal testing. Assessing the mRNA effect in animal trials is a significant step for Ziccum.

The results confirmed well preserved mRNA activity, after the LaminarPace-treated mRNA/LNP materials were administered by injection to mice in a study performed by the CRO partner for animal testing, TrulyLabs AB. The study was performed in a size allowing for statistical significance, over a period of 48 hours after injection. The aim of the study was to investigate the expression of GFP protein (a so-called mRNA reporter) in tumors after injecting mRNA-LNPs, both LaminarPace-treated and non LaminarPace-treated, intratumorally to 4T1 (breast cancer) and MC38 (colorectal cancer) tumors. The animal model choice with tumors was not to predict a cancer treatment effect, but to get well controlled biodistribution. The study was performed by experienced in-vivo experts and in accordance with Swedish legislation. Before start of the study, the experimental procedures have been evaluated and approved by the local ethical committee (5.8.18-16268/2022).

Results demonstrated:

  • Very good preservation of the mRNA activity (In-vivo protein expression level) for mRNA/LNP material treated by LaminarPace.
  • The mRNA activity (In-vivo protein expression level) of the LaminarPace treated samples was on par with non-LaminarPace-treated samples for one of the two tumor types.

In addition to this study, Ziccum is expecting further in-vivo data later in 2024 from the Academic collaboration with University of Copenhagen. These in-vivo trials are work packages in the Ziccum masterplan, ensuring all the necessary steps towards industrial application of the technology, in parallel with development efforts pursued by industry partners for their respective drug projects.

CEO Ann Gidner: “This is a very important step on the journey towards approved treatments – vaccines or therapeutics. LaminarPace mRNA materials are now clearly proven in an animal model. We were anticipating this, based on our range of strong in-vitro data, but we now have clear confirmation in-vivo. Having pre-clinical animal data like this, is key for the pharmaceutical industry. This will be of great value in our partnering dialogues. At Ziccum, we are very pleased to achieve this milestone and we look forward to our onward progress”.

mRNA/LNP data sets

The new results add to a body of data that Ziccum has built up on its LaminarPace-treated mRNA/LNP materials over the last 18 months. Data reported in October 2023 demonstrated strong mRNA activity and confirmed previous positive encapsulation efficiency and particle size preservation readings. In January 2024 the company reported excellent in-vitro mRNA activity and positive readouts in all parameters in a Feasibility Study of the materials, carried out in partnership with a leading Biotech Corporation in the mRNA arena.

mRNA a key priority

mRNA is of central strategic importance to Ziccum. It is the first of three target vaccine platforms the company focuses on. The mRNA/LNP platform was the key enabler of the record-breaking development of Covid-19 vaccines. Investment in the field has boomed. The mRNA market is forecasted to grow to 59 BUSD by 2031 (1). Solving the stability and delivery challenges of the mRNA platform is however a key priority to enable the application across indications and unmet needs. Today, mRNA/LNP products can only be administered as injectables and are fragile and easily damaged, requiring careful cryogenic storage throughout supply chains.

(1) https://www.nature.com/articles/d41573-022-00035-z

Ziccum säkrar finansiering till 2025 genom kombinerad riktad emission och företrädesemission för fortsatt genomförande av den ambitiösa affärsplanen.

EJ FÖR OFFENTLIGGÖRANDE, PUBLICERING ELLER DISTRIBUTION, HELT ELLER DELVIS, DIREKT ELLER INDIREKT, I ELLER TILL USA, AUSTRALIEN, HONGKONG, JAPAN, KANADA, NYA ZEELAND, SCHWEIZ, SINGAPORE, SYDAFRIKA, SYDKOREA, RYSSLAND, BELARUS ELLER I NÅGON ANNAN JURISDIKTION DÄR OFFENTLIGGÖRANDE, DISTRIBUTION ELLER PUBLICERING AV DETTA PRESSMEDDELANDE SKULLE VARA OLAGLIG, KRÄVA REGISTRERING ELLER ANDRA ÅTGÄRDER ÄN SÅDANA SOM FÖLJER AV SVENSK RÄTT. SE ÄVEN AVSNITTET ”VIKTIG INFORMATION” NEDAN.

Styrelsen för Ziccum AB (publ) (”Ziccum” eller ”Bolaget”) har idag, med stöd av bemyndigandet från årsstämman den 24 maj 2023, genomfört en riktad nyemission av 622 371 aktier om cirka 4,2 MSEK (”Riktade Nyemissionen”) till den amerikanska professionella investeraren Global Corporate Finance (”GCF”). Teckningskursen i den Riktade Nyemissionen har fastställts till 6,80 SEK per aktie genom förhandling på armlängds avstånd mellan Bolaget och GCF och motsvarar 7,36 procents rabatt gentemot Bolagets volymvägda genomsnittskurs på Nasdaq First North Growth Market (”First North”) under de fem (5) senaste handelsdagarna. Den Riktade Nyemissionen är en del av ett långsiktigt finansieringsupplägg med GCF inom vilket Ziccum ensidigt äger rätt att påkalla ytterligare investeringar från GCF, i utbyte mot nyemitterade aktier, om motsvarande totalt cirka 2,7 MUSD under de kommande trettio (30) månaderna. Styrelsen i Ziccum har även, med stöd av befintligt bemyndigandet från årsstämman, beslutat om att genomföra en företrädesemission av units (”Units”) om maximalt 10,4 MSEK (”Företrädesemissionen”). Teckningskursen per Unit i Företrädesemissionen uppgår till 6,80 SEK och varje Unit består av en (1) aktie och en (1) vederlagsfri teckningsoption av serie TO5, vilket innebär att teckningskursen per aktie i Företrädesemissionen motsvarar teckningskursen per aktie i den Riktade Nyemissionen. Den Riktade Nyemissionen och Företrädesemissionen genomförs kombinerat för att på ett effektivt sätt säkerställa rörelsekapital för fortsatt offensiv affärsmässig och teknisk utveckling och på ett sätt som ger Bolagets aktieägare möjligheten att delta i finansieringen. Beaktat den Riktade Nyemissionen, och förutsatt att Företrädesemissionen fulltecknas, tillförs Ziccum en initial likvid om totalt cirka 13,5 MSEK, efter avdrag för emissionskostnader om totalt cirka 1 MSEK.

VD Ann Gidner: ”Tack vare väldigt tydliga bekräftelser på att LaminarPace fungerar för den mest krävande och efterfrågade produkten, mRNA i lipidnanopartiklar, och efter att ha skapat en betydande internationell industriposition, har Ziccum en mycket spännande tid framför sig. Det finns ingen annan teknologi som kan göra det vi gör. Varje dag har vi kontakter med potentiella partners som är intresserade av vår teknologi. Vi för affärsdialogerna framåt, levererar på befintliga partnerprojekt samt fortsätter att generera data på nästa nivå, dels genom djurstudier, dels i stabilitetsstudier, under 2024.

Styrelseordförande Fredrik Sjövall: ”Att säkra ytterligare finansiering säkerställer att den snabba utvecklingen i Ziccum kan fortsätta. Genom att kombinera en riktad nyemission till en ny strategisk investerare och en företrädesemission – på lika villkor – lyckas vi tillföra nytt kapital med möjlighet för nuvarande aktieägare att begränsa sin utspädning och fortsätta investera i Ziccum med ökad säkerhet. Dessutom genomförs kapitalanskaffningen till en låg kostnad. Den begränsade aktiekursrabatten har överenskommits baserat på vår starka marknadsposition och våra tydliga affärsmässiga och tekniska framsteg, bekräftat av GCFs due diligence-process. Vårt mål är att göra allt för att skydda befintliga aktieägares värde på bästa möjliga sätt, i ett särskilt utmanande finansieringsklimat.

Live digital pressträff och frågestund, tisdagen den 23 januari, kl 1300

Ziccums styrelseordförande Fredrik Sjövall kommer att delta i en direktsänd pressträff för att presentera bolagets finansiering och svara på frågor. Pressträffen sker i samarbete med Direkt Studios och Investor Targeting. Investerare kan skicka in sina frågor i förväg, eller live under eventet via chatt.

För att skicka in frågor i förväg, skicka dem till moderator Kaarlo Airaxin på: kaarlo.airaxin@investortarget.se

För att delta i evenemanget, gå till: https://www.youtube.com/watch?v=RBO9cXhe3HM

Riktade Nyemissionen

Styrelsen i Ziccum har, med stöd av bemyndigandet från årsstämman den 24 maj 2023, beslutat att genomföra den Riktade Nyemissionen till GCF, bestående av 622 371 aktier till en teckningskurs om 6,80 SEK per aktie. Teckningskursen i den Riktade Nyemissionen har fastställts genom förhandling på armlängds avstånd mellan Bolaget och GCF och motsvarar 7,36 procents rabatt gentemot Bolagets volymvägda genomsnittskurs på First North under de fem (5) senaste handelsdagarna. Genom den Riktade Nyemissionen erhåller Bolaget cirka 4,2 MSEK före emissionskostnader. Av den erhållna nettolikviden har Bolaget valt att kvitta cirka 1,1 MSEK gentemot GCFs fordran på Bolaget för den uppläggningsavgift som Bolaget åtagit sig att betala GCF inom ramen för det långsiktiga finansieringsupplägget mellan Bolaget och GCF. Genom den Riktade Nyemissionen säkerställer Bolaget på ett effektivt sätt rörelsekapital för fortsatt offensiv affärsmässig och teknisk utveckling. Bolaget avser särskilt använda likviden från den Riktade Nyemissionen till att fortsätta exekvera på den ambitiösa tekniska och kommersiella plan som föreligger och för att kunna accelerera pågående och nya affärsdialoger. GCF kommer inte erhålla företrädesrätt i Företrädesemissionen genom den Riktade Nyemissionen.

Bolagets styrelse har noga övervägt möjligheten att anskaffa erforderligt kapital genom enbart en större företrädesemission, men har konkluderat att en sådan företrädesemission (i) skulle vara väsentligt mer tidskrävande samt medföra betydligt högre kostnader och ökad exponering mot potentiell volatilitet på marknaden jämfört med den Riktade Nyemissionen, (ii) givet rådande marknadsförutsättningar och den volatilitet som har kunnat observeras på marknaden, skulle kräva betydande garantiåtaganden från ett emissionsgarantisyndikat för att säkerställa tillräcklig teckning och emissionslikvid, vilket skulle medföra ytterligare kostnader och/eller ytterligare utspädning beroende på vilken typ av ersättning som betalas för sådana garantiåtaganden, (iii) sannolikt skulle behöva göras till en lägre teckningskurs givet de rabattnivåer för företrädesemissioner som genomförts på marknaden nyligen, och (iv) till skillnad från genomförandet av enbart en större företrädesemission innebär den Riktade Nyemissionen att Bolaget tillförs en ny kapitalstark och professionell ägare av strategisk betydelse för Bolaget. Styrelsens samlade bedömning är att skälen för att genomföra den Riktade Nyemissionen med avvikelse från aktieägarnas företrädesrätt överväger skälen som motiverar huvudregeln att nyemissioner ska genomföras med företrädesrätt för aktieägarna och att en nyemission med avvikelse från aktieägarnas företrädesrätt därmed ligger i Ziccums och samtliga aktieägares bästa intresse.

Då teckningskursen i den Riktade Nyemissionen fastställts genom förhandling på armlängds avstånd och motsvarar teckningskursen i Företrädesemissionen är det styrelsens bedömning att teckningskursen är marknadsmässig.

Långsiktigt finansieringsupplägg med GCF

Den Riktade Nyemissionen är en del av ett långsiktigt finansieringsupplägg med GCF (”Avtalet”) inom vilket Ziccum ensidigt äger rätt att påkalla investeringar i separata trancher från GCF om totalt motsvarande 2,7 MUSD, i tillägg till GCFs redan genomförda investering i den Riktade Nyemissionen, under en period om trettio (30) månader. Avtalet innebär således att Ziccum, på kort varsel, har tillgång till finansiering som täcker bolagets budgeterade kostnader fram till 2025.

Varje tranche inom ramen för Avtalet kan uppgå till minst 100 000 USD och maximalt motsvara 500 procent av den genomsnittliga dagliga handelsvolymen i Bolagets aktie under de föregående fjorton (14) handelsdagarna och maximalt fem (5) procent av Bolagets aktuella marknadsvärde. Minst tre (3) veckor måste förflyta mellan varje påkallad tranche. Teckningskursen i varje tranche ska uppgå till det volymvägda genomsnittliga priset för Bolagets aktie på First North under de fem (5) handelsdagar som närmast efterföljer Bolagets påkallande av en tranche (”Beräkningsperioden”) med en rabatt om nio (9) procent. Bolaget och GCF äger var för sig rätt att avbryta en påkallad tranche om det volymvägda genomsnittliga priset under Beräkningsperioden avviker från aktiekursen per dagen för påkallandet med mer än tjugo (20) procent. GCF har åtagit sig att inte sälja aktier i Bolaget under Beräkningsperioden och har vidare åtagit sig att inte blanka eller medverka till tredje parts blankning av Bolagets aktie under hela Avtalets löptid.

Styrelsen för Ziccum har, efter begäran från GCF, tillåtit GCF att genomföra en begränsad bekräftande due diligence i samband med ingåendet av Avtalet. GCF har inom ramen för denna due diligence inte erhållit någon insiderinformation.

Företrädesemissionen

Styrelsen i Ziccum önskar värna samtliga befintliga aktieägares möjlighet att delta i Bolagets finansiering. Styrelsen i Ziccum har därmed, med stöd av bemyndigandet från årsstämman den 24 maj 2023, även beslutat att genomföra Företrädesemissionen i enlighet med följande huvudsakliga villkor.

  • Företrädesemissionen omfattar högst 1 534 015 Units, där varje Unit består av en (1) ny aktie och en (1) teckningsoption av serie TO5. Totalt omfattar Företrädesemissionen därmed högst 1 534 015 aktier och 1 534 015 teckningsoptioner.
  • Den som på avstämningsdagen den 29 januari 2024 är införd i den av Euroclear Sweden AB förda aktieboken äger företrädesrätt att teckna Units i Företrädesemissionen.
  • En (1) befintlig aktie innehavd på avstämningsdagen berättigar till en (1) uniträtt. Nio (9) uniträtter berättigar till teckning av en (1) Unit.
  • Teckningskursen i Företrädesemissionen uppgår till 6,80 SEK per Unit, motsvarande 6,80 SEK per aktie. Teckningsoptionerna emitteras vederlagsfritt. Teckningskursen per aktie i Företrädesemissionen motsvarar teckningskursen i den Riktade Nyemissionen.
  • Sista dag för handel i Ziccums aktie inklusive rätt att erhålla uniträtter är den 25 januari 2024 och första dag för handel exklusive rätt att erhålla uniträtter är den 26 januari 2024.
  • Teckningsperioden i Företrädesemissionen löper från och med den 31 januari 2024 till och med den 14 februari 2024.
  • Handel med uniträtter kommer att ske på First North från och med den 31 januari 2024 till och med den 9 februari 2024.
  • Handel med BTU (betald tecknad unit) kommer att ske på First North från och med den 31 januari 2024 fram till efter Företrädesemissionen registrerats hos Bolagsverket, vilket beräknas ske omkring vecka nio (9), 2024.
  • Ziccum beräknar offentliggöra utfallet i Företrädesemissionen omkring den 16 februari 2024.

Fullständiga villkor och anvisningar för Företrädesemissionen och närmare information om Bolaget kommer att framgå av det informationsmemorandum som kommer att offentliggöras av Bolaget före teckningsperiodens början.

Preliminär tidplan för Företrädesemissionen

  • 25 januari 2024: Sista dag för handel i Ziccums aktie inklusive rätt att erhålla uniträtter
  • 26 januari 2024: Första dag för handel exklusive rätt att erhålla uniträtter
  • 29 januari 2024: Avstämningsdag för deltagande i Företrädesemissionen
  • 30 januari 2024: Beräknad dag för offentliggörande av informationsmemorandum
  • 31 januari 2024 – 14 februari 2024: Teckningsperiod
  • 31 januari 2024 – 9 februari 2024: Handel i uniträtter
  • 16 februari 2024: Beräknad dag för offentliggörande av utfallet i Företrädesemissionen

Villkor för teckningsoptioner av serie TO5

Varje teckningsoption av serie TO5 berättigar till teckning av en (1) ny aktie under perioden från och med den 2 september 2024 till och med den 13 september 2024. Teckningskursen per aktie ska motsvara det lägsta av i) 8 SEK och ii) för det fall Bolaget beslutar om nyemission av aktier med avvikelse från aktieägarnas företrädesrätt mellan den 1 februari 2024 och den 31 augusti 2024, teckningskursen i den senast beslutade sådana nyemissionen (med förbehåll för att teckningskursen aldrig får understiga aktiens kvotvärde). Således kan Bolaget, vid fullt utnyttjande av samtliga Teckningsoptioner, komma att erhålla ytterligare högst cirka 12,3 MSEK före emissionskostnader.

Teckningsoptionerna kommer att tas upp till handel på First North efter att Företrädesemissionen registrerats hos Bolagsverket.

Total ökning av aktiekapital och antal aktier

Genom den Riktade Nyemissionen kommer antalet aktier i Bolaget öka med maximalt 622 371 aktier från 13 806 142 aktier till 14 428 513 aktier och Bolagets aktiekapital öka med maximalt 103 728,64 SEK, från 2 301 023,67 SEK till 2 404 752,17 SEK. Den Riktade Nyemissionen medför en utspädning om cirka 4,3 procent av kapitalet och rösterna för befintliga aktieägare utan hänsyn tagen till Företrädesemissionen.

Efter att den Riktade Nyemissionen registrerats och vid full teckning i Företrädesemissionen kommer antalet aktier i Bolaget att öka med ytterligare 1 534 015 aktier från 14 428 513 aktier till   15 962 528 aktier och aktiekapitalet att öka med ytterligare 255 669,17 SEK från 2 404 752,17 SEK till 2 660 421,33 SEK, motsvarande en utspädningseffekt om cirka 9,6 procent efter att den Riktade Nyemissionen registrerats och för aktieägare som inte deltar i Företrädesemissionen. Vid fullt utnyttjande av samtliga teckningsoptioner som maximalt kan emitteras i Företrädesemissionen kommer antalet aktier att öka med ytterligare 1 534 015 aktier och aktiekapitalet att öka med ytterligare 255 669,17 SEK, till 17 496 543 aktier respektive 2 916 090,5 SEK, motsvarande en ytterligare utspädningseffekt om cirka 8,8 procent.

Vid full teckning i den Riktade Nyemissionen och i Företrädesemissionen samt vid fullt utnyttjande av teckningsoptionerna av serie TO5 kommer antalet aktier att uppgå till 17 496 543 och aktiekapitalet att uppgå till cirka 2 916 090,5 SEK. Den totala utspädningseffekten vid full teckning i den Riktade Nyemissionen och i Företrädesemissionen samt vid fullt utnyttjande av samtliga teckningsoptioner av serie TO5 uppgår därmed till högst cirka 21,1 procent för aktieägare som inte deltar i den Riktade Nyemissionen eller Företrädesemissionen.

Totala emissionskostnader för Företrädesemissionen och den Riktade emissionen uppgår till cirka 1 MSEK.

Rådgivare

Fredersen Advokatbyrå är legal rådgivare och Aqurat Fondkommission agerar emissionsinstitut i samband med den Riktade Nyemissionen och Företrädesemissionen.

För mer information

Digital pressträff och frågestund med Ziccums styrelseordförande Fredrik Sjövall, tisdagen den 23 januari, kl. 1300

Skicka in frågor i förväg på: kaarlo.airaxin@investortarget.se

Närvara vid evenemanget: https://www.youtube.com/watch?v=RBO9cXhe3HM

Ann Gidner, VD
Mail: gidner@ziccum.com
Mobile: +46 722140141

Fredrik Sjövall, styrelseordförande 
E-post:  sjovall@ziccum.com 
Mobil: +46 70 645 08 75

Certified Adviser
Carnegie Investment Bank AB (publ)

[MAR-etikett]

Kort om Ziccum

Ziccum utvecklar LaminarPace, en unik metod för torkning av biologiska läkemedel och vacciner i rumstemperatur. Metoden bygger på massöverföring istället för värmeöverföring. Tekniken licensieras ut till utvecklare och tillverkare av vaccin och biologiska läkemedel inom den globala läkemedelsindustrin. Genom att minska den stress som den aktiva substansen utsätts för under torkningen erbjuder LaminarPace en unik möjlighet att ta fram termostabila biologiska läkemedel med partikel-teknologi i en torr pulverberedning. Dessa är enkla att hantera och transportera och lämpar sig utmärkt för nya administreringssätt. Tekniken har framgångsrikt tillämpats på mRNA, peptider, proteiner, antikroppar, lipider och enzymer, samt på hjälpämnen och adjuvanter, och lämpar sig väl för industriell tillämpning. Ziccum är noterat på Nasdaq First North Growth Market.

VIKTIG INFORMATION

Publicering, offentliggörande eller distribution av detta pressmeddelande kan i vissa jurisdiktioner vara föremål för restriktioner enligt lag och personer i de jurisdiktioner där detta pressmeddelande har offentliggjorts eller distribuerats bör informera sig om och följa sådana legala restriktioner. Mottagaren av detta pressmeddelande ansvarar för att använda detta pressmeddelande och informationen häri i enlighet med tillämpliga regler i respektive jurisdiktion. Detta pressmeddelande utgör inte ett erbjudande om, eller inbjudan att, förvärva eller teckna några värdepapper i Ziccum i någon jurisdiktion, varken från Ziccum eller från någon annan.

Detta pressmeddelande är inte ett prospekt enligt betydelsen i förordning (EU) 2017/1129 (”Prospektförordningen”) och har inte blivit godkänt av någon regulatorisk myndighet i någon jurisdiktion. Inget prospekt kommer att upprättas av Bolaget och publiceras på Bolagets hemsida i samband med Företrädesemissionen.

Detta pressmeddelande utgör inte ett erbjudande om eller inbjudan avseende att förvärva eller teckna värdepapper i USA. Värdepapperna som omnämns häri får inte säljas i USA utan registrering, eller utan tillämpning av ett undantag från registrering, enligt den vid var tid gällande U.S. Securities Act från 1933 (”Securities Act”), och får inte erbjudas eller säljas i USA utan att de registreras, omfattas av ett undantag från, eller i en transaktion som inte omfattas av registreringskraven enligt Securities Act. Det finns ingen avsikt att registrera några värdepapper som omnämns häri i USA eller att lämna ett offentligt erbjudande avseende sådana värdepapper i USA. Informationen i detta pressmeddelande får inte offentliggöras, publiceras, kopieras, reproduceras eller distribueras, direkt eller indirekt, helt eller delvis, i eller till USA, Australien, Hongkong, Japan, Kanada, Nya Zeeland, Schweiz, Singapore, Sydafrika, Sydkorea, Ryssland, Belarus eller någon annan jurisdiktion där sådant offentliggörande, publicering eller distribution av denna information skulle stå i strid med gällande regler eller där en sådan åtgärd är föremål för legala restriktioner eller skulle kräva ytterligare registrering eller andra åtgärder än vad som följer av svensk rätt. Åtgärder i strid med denna anvisning kan utgöra brott mot tillämplig värdepapperslagstiftning.

I Storbritannien distribueras och riktas detta dokument, och annat material avseende värdepapperen som omnämns häri, endast till, och en investering eller investeringsaktivitet som är hänförlig till detta dokument är endast tillgänglig för och kommer endast att kunna utnyttjas av, ”qualified investors” (enligt definitionen i paragraf 86(7) i den brittiska Financial Services and Markets Act 2000) som är (i) personer som har professionell erfarenhet av affärer som rör investeringar och som faller inom definitionen av ”investment professionals” i artikel 19(5) i den brittiska Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (”Föreskriften”); eller (ii) ”high net worth entities” som avses i artikel 49(2)(a)-(d) i Föreskriften (alla sådana personer benämns gemensamt ”relevanta personer”). En investering eller en investeringsåtgärd som detta meddelande avser är i Storbritannien enbart tillgänglig för relevanta personer och kommer endast att genomföras med relevanta personer. Personer som inte är relevanta personer ska inte vidta några åtgärder baserat på detta pressmeddelande och inte heller agera eller förlita sig på det.

Då Ziccum har gjort bedömningen att Bolaget bedriver skyddsvärd verksamhet enligt lag (2023:560) om granskning av utländska direktinvesteringar kan vissa investeringar i Företrädesemissionen förutsätta prövning av Inspektionen för strategiska produkter. För mer information, vänligen besök Inspektionen för strategiska produkters hemsida, www.isp.se, eller kontakta Bolaget.

FRAMÅTRIKTADE UTTALANDEN

Detta pressmeddelande innehåller framåtriktade uttalanden som avser Bolagets avsikter, bedömningar eller förväntningar avseende Bolagets framtida resultat, finansiella ställning, likviditet, utveckling, utsikter, förväntad tillväxt, strategier och möjligheter samt de marknader inom vilka Bolaget är verksamt. Framåtriktade uttalanden är uttalanden som inte avser historiska fakta och kan identifieras av att de innehåller uttryck som ”anser”, ”förväntar”, ”förutser”, ”avser”, ”uppskattar”, ”kommer”, ”kan”, ”förutsätter”, ”bör” ”skulle kunna” och, i varje fall, negationer därav, eller liknande uttryck. De framåtriktade uttalandena i detta pressmeddelande är baserade på olika antaganden, vilka i flera fall baseras på ytterligare antaganden. Även om Bolaget anser att de antaganden som reflekteras i dessa framåtriktade uttalanden är rimliga, kan det inte garanteras att de kommer att infalla eller att de är korrekta. Då dessa antaganden baseras på antaganden eller uppskattningar och är föremål för risker och osäkerheter kan det faktiska resultatet eller utfallet, av många olika anledningar, komma att avvika väsentligt från vad som framgår av de framåtriktade uttalandena. Sådana risker, osäkerheter, eventualiteter och andra väsentliga faktorer kan medföra att den faktiska händelseutvecklingen avviker väsentligt från de förväntningar som uttryckligen eller underförstått anges i detta pressmeddelande genom de framåtriktade uttalandena. Bolaget garanterar inte att de antaganden som ligger till grund för de framåtriktade uttalandena i detta pressmeddelande är korrekta och varje läsare av pressmeddelandet bör inte opåkallat förlita dig på de framåtriktade uttalandena i detta pressmeddelande. Den information, de uppfattningar och framåtriktade uttalanden som uttryckligen eller underförstått framgår häri lämnas endast per dagen för detta pressmeddelande och kan komma att förändras. Varken Bolaget eller någon annan åtar sig att se över, uppdatera, bekräfta eller offentligt meddela någon revidering av något framåtriktat uttalande för att återspegla händelser som inträffar eller omständigheter som förekommer avseende innehållet i detta pressmeddelande, såtillvida det inte krävs enligt lag eller First Norths regelverk för emittenter.

Ziccum secures financing into 2025 through a combined directed share issue and rights issue to finance the continued execution of its ambitious business plan

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, NEW ZEALAND, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, RUSSIA, BELARUS OR IN ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL, REQUIRE REGISTRATION OR ANY OTHER MEASURES THAN THOSE REQUIRED BY SWEDISH LAW. SEE ALSO THE SECTION "IMPORTANT INFORMATION" BELOW.

This Press Release has been drawn up in the Swedish language. In case of any discrepancies between the Swedish text version of this information memorandum and the English translation, the Swedish version shall prevail.

The Board of Directors of Ziccum AB (publ) ("Ziccum" or the "Company") has today, based on authorisation from the Annual General Meeting on 24 May 2023, carried out a directed share issue of 622,371 shares of approximately SEK 4.2 million (the "Directed Share Issue") to the American professional investor Global Corporate Finance ("GCF"). The subscription price in the Private Placement has been set at SEK 6.80 per share through arm's length negotiations between the Company and GCF and corresponds to a 7.36 per cent discount to the Company's volume weighted average price on Nasdaq First North Growth Market ("First North") during the last five (5) trading days. The Directed New Share Issue is part of a long-term financing arrangement with GCF under which Ziccum has the unilateral right to call for additional investments from GCF, in exchange for newly issued shares, totaling approximately USD 2.7 million over the next thirty (30) months. The Board of Directors of Ziccum has also, based on the existing authorisation from the Annual General Meeting, decided to carry out a rights issue of units ("Units") of a maximum of SEK 10.4 million (the "Rights Issue"). The subscription price per Unit in the Rights Issue amounts to SEK 6.80 and each Unit consists of one (1) share and one (1) free warrant of series TO5, which means that the subscription price per share in the Rights Issue corresponds to the subscription price per share in the Directed New Share Issue.

The Directed New Share Issue and the Rights Issue are carried out in combination to effectively secure working capital for continued aggressive business and technical development in the Company in a way that gives the Company's shareholders the opportunity to participate in the financing of the Company. Considering the Directed New Share Issue, and provided that the Rights Issue is fully subscribed, Ziccum will receive initial proceeds totaling approximately SEK 13.5 million, after deduction of issue costs totaling approximately SEK 1 million.

CEO Ann Gidner: “Thanks to crystal clear confirmation of the LaminarPace applicability for the most demanding and in-demand target, mRNA in lipid nanoparticles, and having created significant international awareness in the industry, Ziccum has a very exciting time ahead. There is no other technology that can do what we do. Every day involves interaction with potential partners. We are advancing business dialogues, delivering on existing partner projects, and planning to generate data to get to the next level in animal studies and stability studies in 2024".

Chairman of the Board Fredrik Sjövall: "Securing additional financing ensures that the rapid development of Ziccum can be maintained. With this combination of a directed share issue to a new strategic investor plus a rights issue – on equal terms – we will succeed in raising new capital, whilst making it possible for current shareholders to limit dilution. The combined package enables existing owners to continue investing in Ziccum with increased security, as we minimize the cost of raising capital through efficient execution. The limited share price discount has been agreed based on our strong market position and our excellent business and technological progress, confirmed by the GCF due diligence process. Our aim is to do everything we possibly can to protect the existing shareholders’ value in today’s challenging financial environment".

LIVE DIGITAL PRESS CONFERENCE AND Q&A, TUESDAY 23 JANUARY 1300
Join Ziccum Chairman Fredrik Sjövall as he presents the new Issue and financing agreement – and take investors’ questions – at a live digital Press Conference with Direkt Studios and Investor Targeting. Investors can submit their questions in advance or during the event via chat.
To submit questions in advance, send them to : kaarlo.airaxin@investortarget.se
To attend the event, go to: https://www.youtube.com/watch?v=RBO9cXhe3HM

The Directed New Share Issue
The Board of Directors of Ziccum has, based on authorization from the Annual General Meeting on 24 May 2023, decided to carry out the Directed New Share Issue to GCF, consisting of 622,371 shares at a subscription price of SEK 6.80 per share. The subscription price in the Directed New Share Issue has been determined through arm's length negotiations between the Company and GCF and corresponds to a 7.36 per cent discount to the Company's volume weighted average price on First North during the last five (5) trading days. Through the Directed New Share Issue, the Company receives approximately SEK 4.2 million before issue costs. Through the Directed New Share Issue, the Company efficiently secures working capital for continued aggressive business and technical development in the Company. In particular, the Company intends to use the proceeds from the Directed New Share Issue to continue to execute on its ambitious technical and commercial plan and to accelerate ongoing and new business dialogues. GCF will not receive preferential rights in the Rights Issue through the Directed New Share Issue.

The Company's Board of Directors has carefully considered the possibility of raising the required capital through only a larger rights issue, but has concluded that such a rights issue (i) would be significantly more time-consuming and entail significantly higher costs and increased exposure to potential market volatility compared to the Directed New Share Issue, (ii) given the current market conditions and the volatility that has been observed in the market, would require significant underwriting commitments from an underwriting syndicate to ensure sufficient subscription and issue proceeds, which would entail additional costs and/or further dilution depending on the type of compensation paid for such underwriting commitments, (iii) would likely need to be made at a lower subscription price given the discount levels for rights issues carried out in the market recently, and (iv) unlike the implementation of only a larger rights issue, the Directed New Share Issue means that the Company is provided with a new capital-rich and professional owner of strategic importance to the Company.

The Board of Directors' overall assessment is that the reasons for carrying out the Directed New Share Issue with deviation from the shareholders' preferential rights outweigh the reasons that justify the general rule that new share issues shall be carried out with preferential rights for the shareholders and that a new share issue with deviation from the shareholders' preferential rights is thus in the best interest of Ziccum and all.

As the subscription price in the Directed New Share Issue has been determined through arm's length negotiations and corresponds to the subscription price in the Rights Issue, it is the Board of Directors' assessment that the subscription price is on market terms.

Long-term financing arrangement with GCF
The Directed New Share Issue is part of a long-term financing arrangement with GCF (the "Agreement") under which Ziccum has the unilateral right to call for investments in separate tranches from GCF totalling the equivalent of USD 2.7 million, in addition to GCF's already completed investment in the Directed New Share Issue, for a period of thirty (30) months. The agreement thus means that Ziccum, at short notice, has access to financing that covers the company's budgeted costs up to and including the second quarter of 2025.

Each tranche under the Agreement may amount to a minimum of USD 100,000 and a maximum of 500 per cent of the average daily trading volume of the Company's share during the previous fourteen (14) trading days and a maximum of five (5) per cent of the Company's current market capitalisation. At least three (3) weeks must elapse between each requested tranche. The subscription price in each tranche shall amount to the volume weighted average price of the Company's share on First North during the five (5) trading days immediately following the Company's call for a tranche (the "Calculation Period") with a discount of nine (9) per cent. The Company and GCF are each entitled to cancel a called tranche if the volume-weighted average price during the Calculation Period deviates from the share price on the day of the call by more than twenty (20) per cent. GCF has undertaken not to sell shares in the Company during the Calculation Period and has further undertaken not to short sell or participate in third party short selling of the Company's shares during the entire term of the Agreement.

The Board of Directors of Ziccum has, at the request of GCF, authorised GCF to conduct a limited confirmatory due diligence in connection with the conclusion of the Agreement. In the course of this due diligence, GCF has not received any inside information.

The Rights Issue
The Board of Directors of Ziccum wishes to safeguard the opportunity for all existing shareholders to participate in the Company's financing. The board of directors of Ziccum has therefore, based on the authorization from the Annual General Meeting on 24 May 2023, also decided to carry out the Rights Issue in accordance with the following main conditions.

  • The Rights Issue comprises a maximum of 1,534,015 Units, where each Unit consists of one (1) new share and one (1) warrant of series TO5. In total, the Rights Issue thus comprises a maximum of 1,534, 015 shares and 1, 534, 015 warrants.
  • Those who on the record date of 29 January 2024 are registered in the share register kept by Euroclear Sweden AB have preferential rights to subscribe for Units in the Rights Issue.
  • One (1) existing share held on the record date entitle to one (1) unit right. Nine (9) unit rights entitles the holder to subscribe for one (1) Unit.
  • The subscription price in the Rights Issue amounts to SEK 6.80 per Unit, corresponding to SEK 6.80 per share. The warrants are issued free of charge. The subscription price per share in the Rights Issue corresponds to the subscription price in the Directed New Share Issue.
  • The last day of trading in Ziccum's share including the right to receive unit rights is 25 January 2024 and the first day of trading excluding the right to receive unit rights is 26 January 2024.
  • The subscription period in the Rights Issue runs from 31 January 2024 to 14 February 2024.
  • Trading in unit rights will take place on First North from 31 January 2024 up to and including 9 February 2024.
  • Trading in BTU (paid subscription unit) will take place on First North from 31 January 2024 until after the Rights Issue has been registered with the Swedish Companies Registration Office, which is expected to take place around week nine (9), 2024.
  • Ziccum expects to announce the outcome of the Rights Issue around 16 February 2024.

Complete terms and conditions for the Rights Issue and further information about the Company will be set out in the information memorandum that will be published by the Company before the start of the subscription period.

Preliminary timetable for the Rights Issue

  • 25 January 2024: Last day of trading in Ziccum's share including the right to receive unit rights
  • 26 January 2024: First day of trading excluding the right to receive unit rights
  • 29 January 2024: Record date for participation in the Rights Issue
  • 30 January 2024: Estimated date for publication of information memorandum
  • 31 January 2024 – 14 February 2024: Subscription period
  • 31 January 2024 – 9 February 2024: Trading in unit rights
  • 16 February 2024: Estimated date for publication of the outcome of the Rights Issue

Terms and conditions for warrants of series TO5
Each warrant of series TO5 entitles the holder to subscribe for one (1) new share during the period from and including 2 September 2024 up to and including 13 September 2024. The subscription price per share shall correspond to the lowest of i) SEK 8 and ii) in the event that the Company resolves on a new issue of shares with deviation from the shareholders' preferential rights between 1 February 2024 and 31 August 2024, the subscription price in the most recently resolved such new issue (subject to the fact that the subscription price may never fall below the quota value of the share). Thus, upon full exercise of all Warrants, the Company may receive an additional maximum of approximately SEK 12.3 million before issue costs.

The Warrants will be admitted to trading on First North after the Rights Issue has been registered with the Swedish Companies Registration Office.

Total increase in share capital and number of shares
Through the Directed New Share Issue, the number of shares in the Company will increase by a maximum of 622,371 shares from 13,806,142 shares to 14,428,513 shares and the Company's share capital will increase by a maximum of SEK 103,728.64, from SEK 2,301,023.67 to SEK 2,404,752.17. The Directed New Share Issue entails a dilution of approximately 4.3 per cent of the capital and votes for existing shareholders without taking into account the Rights Issue.

After the Directed New Share Issue has been registered and upon full subscription to the Rights Issue, the number of shares in the Company will increase by an additional 1,534,015 shares from 14,428,513 shares to 15,962,528 shares and the share capital will increase by an additional SEK 255,669.17 from SEK 2,404,752.17 to SEK 2,660,421.33, corresponding to a dilution effect of approximately 9.6 per cent after the Directed New Share Issue has been registered and for shareholders who do not participate in the Rights Issue. Upon full exercise of all warrants that can be issued in the Rights Issue, the number of shares will increase by an additional 1,534,015 shares and the share capital will increase by an additional SEK 255,669.17, to 17,496,543 shares and SEK 2,916,090.5 respectively, corresponding to an additional dilution effect of approximately 8.8 per cent.

Upon full subscription in the Directed New Share Issue and the Rights Issue and upon full exercise of the warrants of series TO5, the number of shares will amount to 17,496,543 and the share capital will amount to approximately SEK 2,916,090.5. The total dilution effect upon full subscription in the Directed New Share Issue and the Rights Issue and upon full exercise of all warrants of series TO5 thus amounts to a maximum of approximately 21.1 per cent for shareholders who do not participate in the Directed New Share Issue or the Rights Issue.

The total issue cost will amount to approximately SEK 1 million for the combined Directed Issue, Long-term financing arrangement and the Rights Issue. Of the net proceeds received, the Company has chosen to offset approximately SEK 1.1 million against GCF's claim on the Company for the arrangement fee that the Company has undertaken to pay GCF under the long-term financing arrangement between the Company and GCF.

Advisors
Fredersen Advokatbyrå is legal advisor and Aqurat Fondkommission is acting as issuing agent in connection with the Directed New Share Issue and the Rights Issue.

For further information

Join Chairman Fredrik Sjövall for a live digital Press Conference and Q&A, Tuesday 23 January 1300
To submit questions in advance, send them to : kaarlo.airaxin@investortarget.se
To attend the event, go to: https://www.youtube.com/watch?v=RBO9cXhe3HM

Ann Gidner, CEO
Mail: gidner@ziccum.com
Mobile: +46 722140141

Fredrik Sjövall, Chairman of the Board
E-mail: sjovall@ziccum.com
Mobile: +46 70 645 08 75

Certified Adviser
Carnegie Investment Bank AB (publ)

IMPORTANT INFORMATION
The publication, announcement or distribution of this press release may, in certain jurisdictions, be subject to legal restrictions and persons in the jurisdictions where this press release has been published or distributed should inform themselves about and observe such legal restrictions. The recipient of this press release is responsible for using this press release and the information contained herein in accordance with the applicable rules in each jurisdiction. This press release does not constitute an offer or an invitation to acquire or subscribe for any securities in Ziccum in any jurisdiction, neither from Ziccum nor from anyone else.

This press release is not a prospectus within the meaning of Regulation (EU) 2017/1129 (the "Prospectus Regulation") and has not been approved by any regulatory authority in any jurisdiction. No prospectus will be prepared by the Company and published on the Company's website in connection with the Rights Issue.

This press release does not constitute an offer or invitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States absent registration or an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of such securities in the United States. The information contained in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, in or into the United States, Australia, Hong Kong, Japan, Canada, New Zealand, Switzerland, Singapore, South Africa, South Korea, Russia, Belarus or any other jurisdiction where such announcement, publication or distribution of this information would be contrary to applicable law or where such action is subject to legal restrictions or would require additional registration or other measures than those required by Swedish law. Actions in contravention of this guidance may constitute a breach of applicable securities laws.

In the United Kingdom, this document and other materials relating to the securities referred to herein are only being distributed and directed to, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, "qualified investors" (as defined in section 86(7) of the Financial Services and Markets Act 2000) who are (i) persons who have professional experience in matters relating to investments and who fall within the definition of "investment professionals" in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); or (ii) "high net worth entities" as referred to in Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). An investment or investment activity to which this communication relates is available in the United Kingdom only to relevant persons and will be engaged in only with relevant persons. Persons who are not relevant persons should not take any action based on this announcement and should not act or rely on it.

As Ziccum has made the assessment that the Company conducts activities worthy of protection under the Act (2023:560) on review of foreign direct investments, certain investments in the Rights Issue may require review by the Swedish Inspectorate for Strategic Products. For more information, please visit the Swedish Inspectorate for Strategic Products' website, www.isp.se, or contact the Company.

FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements that reflect the Company's intentions, beliefs or expectations regarding the Company's future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that do not relate to historical facts and can be identified by the fact that they contain expressions such as "believes", "expects", "anticipates", "intends", "estimates", "will", "may", "assumes", "should", "could" and, in each case, negatives thereof, or similar expressions. The forward-looking statements in this press release are based on various assumptions, many of which are based on additional assumptions. Although the Company believes that the assumptions reflected in these forward-looking statements are reasonable, there can be no assurance that they will materialise or that they are accurate. Because these assumptions are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcomes may differ materially from those in the forward-looking statements for a variety of reasons. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied by the forward-looking statements in this press release. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are correct and any reader of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements expressed or implied herein speak only as of the date of this press release and are subject to change. Neither the Company nor anyone else undertakes to review, update, confirm or publicly announce any revision to any forward-looking statement to reflect events that occur or circumstances that arise in relation to the content of this press release, unless required by law or First North's Rulebook for Issuers.

Ziccum reports successful mRNA/LNP Feasibility Study with major Biotech Corporation

Ziccum and its Biotech Corporation collaboration partner have now reviewed the outcomes of the LaminarPace Feasibility study of mRNA/LNP materials, under the agreement signed on May 9th 2023. The study was very successful, and both parties confirm consistent, positive readouts in the Study’s major parameters.

 
The joint assessment meeting reviewing the readouts took place on January 9, 2024. It concluded that the LaminarPace treatment performed very successfully in the Study’s agreed-upon metrics:

mRNA activity: the assessment concluded that the resulting dry powder material demonstrated excellent mRNA activity, when reconstituted and tested in in-vitro cell studies. This is a must for the resulting mRNA treatment to have its effect, for vaccine immunisation or therapeutic effect.

Encapsulation efficiency: the assessment concluded that the LaminarPace treatment resulted in well-preserved mRNA content in LNP particles with adequate encapsulation efficiency. This is an important metric in the production economics of mRNA/LNP, preserving the very expensive mRNA materials.

Particle preservation and distribution: the assessment concluded that the treatment resulted in well preserved lipid nanoparticles with good particle size and preserved size distribution. This is important for having a final drug composition which can be administered to patients.

Product reconstitution: the partner assessment confirmed the consistent Ziccum findings that LaminarPace-treated material can be reconstituted (dissolved back into liquid) very quickly and smoothly, with no foaming, precipitation, or other practical issues.

The Ziccum evaluation and the Biotech Corporation partner’s evaluation both delivered consistent results that matched very closely.
 
Based on these clear, satisfactory results, a continued dialogue on the potential next phase of collaboration in potential applications may be initiated.

Ziccum CEO Ann Gidner: “These results, from a world-leading player in the field, confirm LaminarPace’s ability to turn mRNA/LNP liquid biological material into a thermostable dry powder, with all its advantages, retaining excellent mRNA activity in cells. This is exciting and rewarding news. We are grateful for excellent partner interaction, and our partner concluding that the collaboration was a success. Let me express my appreciation to the Ziccum team for their great efforts delivering these results”.

Ziccum Chairman Fredrik Sjövall: “It is of utmost importance to Ziccum to have this validation of the applicability of LaminarPace technology also for mRNA/LNP treatments. We are keenly looking forward to the potential of applying LaminarPace in this field, with many potential applications and partners.”

Ziccum signs agreement for Vaccine Evaluation project with major US Biomanufacturing corporation

Ziccum AB (publ) (‘Ziccum’) has signed a Material Transfer and Evaluation Agreement for a Vaccine Evaluation project with one of the most important technology-focused Biomanufacturing corporations in the US. The project is funded and will focus on evaluating the potential for new dry, thermostable forms of an advanced viral vaccine, using Ziccum’s unique formulation and drying technology LaminarPace. Ziccum has signed three agreements for funded partner studies since May 2023, and these add up to combined revenues of 10 MSEK.

The new agreement is the third major partner contract for funded Feasibility studies that Ziccum has signed in recent months. It significantly broadens the company’s strategic and biotherapeutic position. Strategically, it is the first agreement for the company with a Biomanufacturing corporation- a vital industry segment in vaccine manufacturing.

The project aims to evaluate Ziccum’s unique formulation and drying technology, LaminarPace, for treatment of an advanced viral vaccine material. The material belongs to one of the three high-potential vaccine platforms that Ziccum targets and has worked on in-house. If successful, the project will represent a significant step forward in demonstrating LaminarPace’s potential across markets and modalities.

Ziccum’s new partner company is one of the US’ largest technology-focused Biomanufacturing corporations. It has a portfolio of domestic and international partners providing advanced, end-to-end manufacturing solutions for comprehensive pandemic preparedness. The company has capabilities in vaccines, gene therapy, cell therapy, nucleic acids and more.

This third agreement for funded studies signed with a major, international corporation in recent months confirms the significant acceleration Ziccum has made in its business development and strategic and scientific progress over the last year since the appointment of new CEO Ann Gidner in 2022. In total, the three agreements for partner studies give Ziccum a combined revenue of 10 milion SEK for the initial steps agreed upon.

Ziccum Chairman Fredrik Sjövall: “This is a great step forward for us strategically, covering a new vaccine platform and an important new key market segment. We can’t wait to get the project started!”

CEO Ann Gidner: “We are honored that our technology will be evaluated by such an important partner for technological and medical advancement. As someone with extensive experience in Biomanufacturing industry right from its inception, I’m aware of the competitive advantage the future use of LaminarPace could generate for this type of partner. This Agreement reflects that innovation in vaccine formulation, and new stable and thermostable formulations, could play a fantastic role in making the world better prepared for pandemics.”

Ziccum signs Evaluation Agreement for Feasibility Study with major global Pharmaceutical Corporation

As of today, Ziccum AB (publ) (‘Ziccum’) has signed a new Evaluation Agreement with a major global Pharmaceutical Corporation. The agreement is to perform a funded Feasibility study aiming to develop thermostable dry powder formulations in the partner mRNA/LNP projects, with a planned extension for stability testing and an option to license the LaminarPace technology.

Ziccum’s new partner is one of the world’s top pharmaceutical corporations. The new agreement is for a funded Feasibility study aiming at developing dry powder versions of the partner’s mRNA/LNP materials. The formal terms of the agreement include a planned extension including stability testing, if the first step is successful, plus an option for the Pharmaceutical Corporation to negotiate a license to the LaminarPace technology.

Since May 2022, Ziccum has created a substantial pipeline of new dialogues within the pharmaceutical industry. In parallel the company strengthened its focus on mRNA in lipid nanoparticles (LNPs), with proof of drying mRNA/LNP materials with well-preserved vaccine activity in March 2023. mRNA in LNP formulation is the vaccine technology that was key to the rapid development of Covid-19 vaccines and is currently one of the most fast-developing fields within pharmaceutical development world-wide. During spring, CEO Ann Gidner has presented the Ziccum mRNA/LNP capabilities and findings, fueling industry interest, at several international summits and conferences.

This is the second agreement Ziccum has signed with a leading global pharmaceutical corporation in just over two months, thanks to the significant scientific and commercial progress the company has made based on new strategy and new leadership. The agreement signing is a milestone achievement in Ziccum’s Project Portfolio. 

The current project is expected to commence in July 2023 and the first stage will run for a number of months. Both parties will be evaluating the properties of the resulting materials.

CEO Ann Gidner: “The Ziccum team is certainly excited to begin this important and well-designed project in such a valuable field. Partnering up with this high caliber Pharma Corporation is an honor for us, and it brings significant future business potential. Hopefully generating excellent results, this collaboration can enable important advantages in the development of mRNA/LNP treatments for our partner.”

Open post

Ziccum appoints senior biopharma executive as new CFO

Ziccum AB (publ) has appointed Johny Humaloja as its new CFO. Johny is a financial executive with decades of experience in the biopharma and biotech industries in Europe and the US. He will assume his new position on June 15. CEO Ann Gidner: “Johny’s profile is a perfect fit for us, as we keep moving forward. His appointment both contributes to and confirms our current international trajectory. We welcome him warmly”.

Johny Humaloja has extensive experience as a financial and controller executive in biopharma, biotech and medtech. He has served in senior positions in Europe and the US and is joining Ziccum from the position as CFO of Amniotics AB, where amongst other achievements he led the company through a successful IPO and listing on Nasdaq first north (in 2021). He will assume his new role at Ziccum on June 15th 2023.

Johny has an Executive MBA in Economics & Management from Lund University as well as a BSc in Business Administration & Economics. He brings extensive operational and industrial experience; he has served as a CFO, Financial and Logistics Director, Financial Control Director and as Plant Controller in the US of a large-scale biotech manufacturing facility with an annual budget of 110 MUSD. This is valuable additional expertise for Ziccum, which is taking its unique pharmaceutical drying technology LaminarPace forward to industrialization through international partnering by its licensing business model.

Johny’s appointment is part of the dynamic growth and development agenda at Ziccum. The company is currently also seeking to recruit a Chief Operating Officer, with international biopharma experience, as it continues to broaden and strengthen its strategic executive expertise. Ziccum’s current CFO, Frida Hjelmberg, will remain in the company for a good transition period.

CEO Ann Gidner: “I am delighted to welcome Johny to Ziccum. As we go forward driving partnered projects for licensing, a new team member with relevant, in-depth industry experience will be a great asset. I would like to thank Frida Hjelmberg for her dedicated work over the last few years. It has been a pleasure working with her. We look forward to having Johny onboard”.

Johny Humaloja: “this is a highly interesting opportunity and I’m very excited to join Ziccum, a true leader in its field with a unique technology and with significant potential. I look forward to helping the company realize that potential, moving Ziccum forward on its financial, operational, and transformational path, and driving an accelerated long-term growth journey”.

Ziccum signs Evaluation Agreement with Biopharmaceutical Corporation focused on mRNA technologies

Ziccum AB (publ) (‘Ziccum’) has signed an Evaluation agreement with a Biopharmaceutical Corporation focused on mRNA technologies to commence a Feasibility study regarding LaminarPace for ambient drying of mRNA/LNP materials and/or mRNA vaccine(s). mRNA is a top strategic priority for Ziccum, and in March 2023 it announced positive results in its in-house project, drying active mRNA in LNP formulation.

Ziccum AB (publ) (‘Ziccum’) has signed an Evaluation agreement with a Biopharmaceutical Corporation focused on mRNA technologies. This new agreement is for a fully financed Feasibility study, formulating and drying mRNA/LNP materials with LaminarPace ambient drying.

The Evaluation agreement signing is a milestone achievement in one of the highlighted partnering dialogues in Ziccum’s regularly updated Project Portfolio overview. Since 2022, following new leadership and a significant strategic refocus, Ziccum has successfully pursued a dynamic partnering agenda, creating a pipeline of industrial dialogues.

The agreement is the result of keen interest in the LaminarPace technology to generate dry powder materials in mRNA/LNP technology development. This is based on successful results on the mRNA/LNP platform for LaminarPace, an entirely new drying technology making dry powder biopharmaceuticals possible. The Feasibility study is expected to start in May 2023.

CEO Ann Gidner: “We are delighted to sign this agreement with such an important, leading mRNA player and to continue work in this highly interesting field. For us at Ziccum this collaboration confirms the strong interest for our novel technology, enabling thermostable biopharmaceuticals in general and the most fragile mRNA/LNP in particular, and it confirms our outreach in the international Pharma industry. We are indeed excited to move forward.”

Chairman Fredrik Sjövall: “This agreement is a breakthrough for Ziccum and a strong acknowledgement of what our technology can offer the key players in this industry. It also confirms our new strategy, business model and capability to move partnering dialogues forward, thanks to the combination of good leadership and strong technical data being generated in well-defined internal trials.”

Ziccum awarded 10 MSEK Eurostars funding for 3D-modeling and Digital twin project

Ziccum AB has been awarded non-dilutive funding of 10 MSEK by Eurostars for a joint application with the Institute of Computational Physics (ICP) at the School of Engineering at Zurich University of Applied Sciences (ZHAW). The project (application # 2,199 LaPaSim) is to apply 3D-modelling to Ziccum’s ambient drying system for biopharmaceuticals, LaminarPace, resulting in a digital twin. International competition for the funding was intense, and the proposal was one of the highest-ranked applications.

On September 14th, 2022 Ziccum and ZHAW announced their joint Eurostars application for funding towards a project applying 3D-modelling and developing a Digital twin of LaminarPace. Ziccum has now received notification that the project has been awarded the maximum 10 MSEK in funding. The project begun in June 2022 and will run over three years, where Ziccum is engaging the Research Area Multiphysics Modeling and Imaging team of ICP at ZHAW’s School of Engineering, led by Prof. Dr. Gernot Boiger, for advanced 3D-modeling.

The project is accelerating the industrial development, tech transfer and scaleout of LaminarPace as a unit of pharmaceutical production. As an ambient drying technology, LaminarPace uniquely is drying biopharmaceuticals by mass transfer instead of heat transfer, avoiding heat stress as well as mechanical stress to the delicate active ingredients – thus enabling high yields, thermostability and processing benefits.

Competition for the Eurostars funding was intense. The joint proposal was praised for its quality and strong business plan by the Eurostars evaluation team who pointed out the “very tough international assessment the applications go through”. The joint proposal was one of the highest-ranking projects.

The successful application is a firm validation of Ziccum’s sharpened strategic focus, technology development ambitions and new business plan. This plan encompasses critical technology optimization and the offering of new formulation and technology licenses to pharma, biotech and drug manufacturing partners.

Ziccum CEO Ann Gidner: “We are indeed happy and proud to have been awarded this grant, thanks to a high-ranking proposal developed in close collaboration with the ZHAW expert team. It is an excellent validation of our strategic focus and newly developed business plan. We used no external agency to produce this proposal – it was the product of our combined internal expertise. We look forward to moving ahead together on this important project.”

Ziccum Chairman Fredrik Sjövall: “I congratulate Ann and our team for their outstanding proposal and focused technology development. This is also a welcome financial reinforcement for Ziccum. This project is at an exciting stage in development, and I look forward to seeing it move ahead.”

About ICP and ZHAW

The Research Area Multiphysics Modeling and Imaging team of the ICP at at the School of Engineering at ZHAW is made up of 20 simulation experts, physicists, mathematicians and engineers led by Prof. Dr. Gernot Boiger. The team has carried out projects modeling particle flow across industries including pharmaceuticals, aerospace, energy, automotive and more.

About Eurostars

The Eurostars organization specializes in projects that partner SMEs such as Ziccum with larger companies, universities and research organizations. It funds R&D collaborations across 37 member countries. Eurostars is co-funded by the EU Horizon 2020 Framework Programme and EUREKA, the world’s largest public network for international cooperation in R&D and innovation.

The above is information that Ziccum is obliged to make public pursuant to EU Market Abuse Regulations (MAR). The information was submitted for publication, through the agency of the contact persons set out above, on 2022-12-16 at 20:00 CEST.

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